BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMPSON BASYE SPECULUM

    MDR report key: 10366 · Received November 3, 1993

    Report

    Report Number
    10366
    Event Type
    Other
    Date Received
    November 3, 1993
    Date of Event
    October 27, 1993
    Report Date
    November 2, 1993
    Manufacturer
    SIMPSON/BASYE
    Product Code
    HIC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DUE TO A BREAK IN THE INTEGRITY OF THE INSULATED SURFACE OF SPECULUM AN ELECTRICAL ARC CAUSED A RIGHT VAGINAL WALL BURN DURING A LOOP EXCISION OF THE CERVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPSON BASYE SPECULUM INSULATED VAGINAL SPECULUM HIC SIMPSON/BASYE

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other